Cardiovascular Outcomes in Bariatric Surgery Patients With Type 2 Diabetes

Overview

The objective of the analysis was to evaluate the relationship between bariatric surgery and cardiovascular outcomes in obese patients with type 2 diabetes. This is a retrospective matched cohort study of patients with diabetes that underwent bariatric surgery at the Cleveland Clinic between 2004-2017. Each bariatric patient was matched to a non-surgical control with obesity and type 2 diabetes in a 1:5 ratio using data from the Electronic Medical Record (EMR). The maximum observation time was 10 years. Cumulative incidence rates for all-cause mortality and cardiovascular events were calculated at years 1, 3, 5, 7 and 10. Kaplan-Meier curves were created for all the outcomes with all-cause mortality considered as a completing risk.

Full Title of Study: “Cardiovascular Outcomes in Patients With Type 2 Diabetes and Obesity: Comparison of Metabolic Surgery Versus Usual Care”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: July 12, 2019

Interventions

  • Procedure: Bariatric Surgery
    • Patients chosen using the following codes: Current Procedural Terminology (CPT): 43633, 43634, 43770, 43775, 43644, 43645, 43659, 43842, 43843, 43844, 43845, 43846, 43847 International Classification of Diseases (ICD): 44.31, 43.82,44.95, 43.89, 44.38, 44.39, 44.68 Healthcare Common Procedure Coding System (HCPCS): S2082, S2085

Arms, Groups and Cohorts

  • Bariatric Surgery
    • Patients with type 2 diabetes with BMI >=30 that underwent bariatric surgery
  • Non-Surgical Control
    • Matched non-surgical controls with type 2 diabetes and BMI >=30

Clinical Trial Outcome Measures

Primary Measures

  • Composite of All-Cause Mortality and Cardiovascular Outcomes
    • Time Frame: From index date through a maximum of 10 years
    • Time to first occurrence of all-cause mortality, coronary artery disease event, stroke, heart failure, nephropathy, or atrial fibrillation

Secondary Measures

  • Incidence of Major Adverse Cardiovascular Event (MACE-3)
    • Time Frame: From index date through a maximum of 10 years
    • Time to first occurrence of all-cause mortality, myocardial infarction or ischemic stroke
  • All-Cause Mortality
    • Time Frame: From index date through a maximum of 10 years
    • Time to occurrence of death from any cause
  • Incidence of Coronary Disease Events
    • Time Frame: From index date through a maximum of 10 years
    • Time to first occurrence of myocardial infarction, unstable angina, percutaneous coronary intervention, or coronary artery bypass grafting
  • Incidence of Cerebrovascular Events
    • Time Frame: From index date through a maximum of 10 years
    • Time to first occurrence of ischemic or hemorrhagic stroke, carotid stenting or endarterectomy
  • Incidence of Heart Failure
    • Time Frame: From index date through a maximum of 10 years
    • Time to first occurrence of heart failure
  • Development of Nephropathy
    • Time Frame: From index date through a maximum of 10 years
    • Time to first occurrence of nephropathy defined as >=2 measures of estimated Glomerular Filtration Rate (eGFR) <60 ml/min/1.73m^2 separated by at least 90 days without intervening values >=60
  • Incidence of Atrial Fibrillation
    • Time Frame: From index date through a maximum of 10 years
    • Time to first occurrence of atrial fibrillation defined by the following codes: International Classification of Diseases ICD-9: 427.31 ICD-10: i48.0, i48.1, i48.2, i48.91 Current Procedural Terminology (CPT): 93650, 93653, 93656, 93657

Participating in This Clinical Trial

Inclusion Criteria

  • Type II diabetes – 18-80 years old – BMI>=30 – HBA1c >6.4 OR taking at lease one (1) diabetes medication (insulin or non-insulin) Exclusion Criteria:

  • History of liver, heart, or lung transplant – Emergency department admission within 5 days prior – Cancer diagnosis within 1 year prior – Any prior ejection fraction <20% – Non-surgical controls were excluded if they died within 30 days after the index date (date of surgery for the bariatric patients) – Last follow-up date on or before the index date

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The Cleveland Clinic
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ali Aminian, Principal Investigator – The Cleveland Clinic
  • Overall Official(s)
    • Phil Schauer, MD, Principal Investigator, The Cleveland Clinic

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